Remote Clinical Compliance Manager (GCP & QA)

Parexel; Madrid; Remote; EUR 70,000 - 110,000; Full time

Job summary

Parexel is seeking an experienced Compliance Manager to provide GCP compliance support for clinical study teams in a fully remote capacity. The role focuses on regulatory requirements, SOPs, risk management, and CAPA processes across global trials.

The ideal candidate will have 5+ years in clinical compliance or quality assurance, strong insight into ICH GCP, and experience with CRO/vendor governance to ensure audit readiness and quality across therapeutic areas.

Qualifications

• Minimum 5 years clinical operational experience, e.g. clinical trial manager, clinical compliance manager, clinical project manager, etc.
• Experience in a clinical compliance, quality assurance, or regulatory compliance role.
• Solid experience as a Clinical Trial Manager, CRA, and/or auditor; and/or a combination of any of these roles
• Solid experience in Phase I, II, and III clinical trials
• Experience - at minimum 5 years; any CRO experience must have been in global trials
• Health Agency Inspection experience
• Thorough knowledge and understanding of drug development and the clinical trial process.
• In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.
• Working knowledge of CAPA management, risk management, regulatory inspections.

Responsibilities

• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
• Identify and elevate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.
• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
• Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
• Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.
• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
• Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Job description

Parexel is seeking an experienced Compliance Manager to provide GCP compliance support for clinical study teams in a fully remote capacity. The role focuses on regulatory requirements, SOPs, risk management, and CAPA processes across global trials.

The ideal candidate will have 5+ years in clinical compliance or quality assurance, strong insight into ICH GCP, and experience with CRO/vendor governance to ensure audit readiness and quality across therapeutic areas.